Drug application
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE)
Drugs@FDA ANDA 077170 · IVAX SUB TEVA PHARMS
Key facts
| Drug name | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 077170 |
| Company | IVAX SUB TEVA PHARMS |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | 5MG;120MG |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Feb 25, 2008 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: